HSA TelehealthTelehealth R2.1
Telehealth R2.1 is the official HSA identifier for “Regulatory Guidelines for Telehealth Products (Revision 2.1)”. Telehealth R2.1 is the official identifier HSA uses for this instrument.
- Instrument
- Telehealth
- Full name
- Telehealth R2.1
- Category
- Software/SaMD
- Authority source
- English
- Readable HTML
- 7 articles · 1 language version
- Published
- April 2019
- Effective
- —
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Each version has stable article anchors for direct citations and highlighting. The readable text is generated from an authority source and does not replace the legally controlling publication.
Regulatory Guidelines for Telehealth Products (Revision 2.1)
HSA guideline (Revision 2.1, April 2019) on when telehealth products — hardware, software, and mobile applications — are regulated as medical devices, their GN-13 risk classification, and the applicable registration, dealer-licensing, and post-market controls, including the Immediate Registration Route for standalone mobile applications. Exact PDF from the official guidance-documents collection. Ingested as sec-1 through sec-5 with both decision flowcharts kept as first-class anchored blocks; inline R2.0/R2.1 revision-highlight markers are stripped as change-tracking furniture, and the graphical Table 2 (evaluation-route eligibility criteria) carries a caption-only text layer, so the table itself is not machine-readable in the source.
Telehealth R2.1 is the official identifier HSA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.